MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-11 for LYOPHILIZED CHEMISTRY CALIBRATOR DR0070-1, DR0070-2 manufactured by .
[80059735]
A field action (fa 31857) for the mismatched lots of au lyophilized calibrator part dr0070-1, lot 6101k51/6101k61 has been implemented on (b)(4) 2017. The beckman coulter internal identifier for this report is (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[80059736]
The customer reported a low shift in quality control for calcium. Upon troubleshooting, it was discovered that the customer was shipped mismatched lots of calibrator. The customer used mismatched lots to calibrate and ran patient samples which generated results exceeding assay total precision claims on multiple chemistries for thirty seven (37) patients. The original results were reported out of the laboratory. Upon repeating patient samples using the corrected calibrator lot and its set-points, the customer compared the original results and repeated results and believed the differences were insignificant. The customer did not amend the results. The customer confirmed there was no change to patient treatment. Quality control was within their established range before the event. The customer noted a shift in calcium qc but it was within their established range.
Patient Sequence No: 1, Text Type: D, B5
[91086087]
A field action (fa 31857) for the mismatched lots of au lyophilized calibrator part dr0070-1, lot 6101k51/6101k61 has been implemented on (b)(4) 2017. The beckman coulter internal identifier for this report is (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2017-00021 |
| MDR Report Key | 6704557 |
| Date Received | 2017-07-11 |
| Date of Report | 2017-06-14 |
| Date of Event | 2017-06-14 |
| Date Mfgr Received | 2017-06-14 |
| Device Manufacturer Date | 2015-01-01 |
| Date Added to Maude | 2017-07-11 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR DAVID DAVIS |
| Manufacturer Street | 250 S. KRAEMER BLVD M/S E1.SE.01 |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149613796 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | FA 31857 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | LYOPHILIZED CHEMISTRY CALIBRATOR |
| Generic Name | CALIBRATOR, MULTI-ANALYTE MIXTURE |
| Product Code | JIX |
| Date Received | 2017-07-11 |
| Model Number | NA |
| Catalog Number | DR0070-1, DR0070-2 |
| Lot Number | 6101K51, 6102K61 |
| Device Expiration Date | 2018-01-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer Address | BECKMAN COULTER 250 S KRAEMER BLVD BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-11 |